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Sex
Drugs: The Second Generation
by
Stanley Ducharme, Ph.D.
On
March 28, 1998, we ushered in a new era in the sexual revolution.
Never in recent memory had a medication received the publicity
or popularity of Sidenafil (Viagra). In fact, only the birth
control pill had ever come close to prompting the societal
and cultural changes brought on by the little blue pill.
Even
today after 4 years on the market, over 11,000 prescriptions
are written each day by primary care doctors and urologists
in the United States alone. No statistics are available
for the number of prescriptions sold via the internet but
clearly that number is extremely high. For many people,
the confidentiality of the internet provides a safe mechanism
to obtain prescriptions and to order refills. In addition,
Viagra is sold on the “black market” in many cities
throughout the US and worldwide.
Statistics
for Viagra have demonstrated the wide spread use of the
medication. Of those individuals who use Viagra, 58% of
men report that they use Viagra each time they are sexually
active. Despite the fact that most insurance companies will
pay for a maximum of 4 pills per month, the average number
of pills taken each month ranges from 5 to 6 doses. In addition,
72% of men using Viagra report that the 100mg dosage is
necessary to achieve sufficient rigidly for vaginal penetration
while 28% of men report that they typically cut the 100mg
pill into two or three pieces. This procedure helps to reduce
the cost of each dose. The 25mg dosage is virtually never
prescribed.
In
spite of its popularity and effectiveness, Viagra has proven
to be far from the perfect solution to erectile dysfunction.
Many men, such as individuals with severe cardiovascular
disease, curvatures of the penis or prostate cancer have
found the medication to be ineffective. Complaints about
the loss of spontaneity are commonplace. The cost is also
prohibitive for many couples. Eating a meal or drinking
alcohol tend to reduce its potency. The use of nitroglycerine
is contraindicated. Finally, severe headaches, visual disturbances,
a stuffy nose and nausea are frequently reported as adverse
reactions.
For
men with neurological injury or disease, Viagra has been
especially effective and generally a welcome addition to
the more traditional invasive treatments for erectile dysfunction.
The use of injection therapies and the use of the vacuum
pump have drastically declined among men with various disabilities.
Furthermore, the penile prosthesis, once the treatment of
choice for men with spinal cord injury, is rarely ever used
except in cases where other systemic medical issues have
a significant negative impact on the quality of erections.
Despite Viagra’s popularity, public concerns about
cost, the lack of insurance coverage and negative side effects
make Viagra unobtainable and unusable for many men. Many
women are also fearful of potential dangerous side affects
that could harm their husband or partner.
With
the mounting concerns about the cost and side effects of
Viagra, the time has been ripe for competition to Pfizer’s
“miracle drug”. Fortunately, we won’t be
disappointed. The year 2002 promises to be an exciting year
in the sexual arena. This year and in 2003, the second generation
“Viagras” will make their debut. As expected,
they’ll be better, quicker acting and more effective
than what is currently available. Not only can we expect
the second-generation pills to be more potent; the pharmaceutical
industry even has a few surprises in store for us!
On
September 21, 2001, Bayer Pharmaceutical Company applied
for FDA approval for it’s new erection medication,
Vardenafil. As of this writing the company has not released
the brand name for Vardenafil and some last minute name
changes have occurred. Regardless of name, the new Bayer
product will have many distinct advantages to today’s
oral erectile medication and is expected to be released
by late 2002.
Bayer
promises that Vardenafil will out perform Sidenafil in all
the important aspects of safety, effectiveness, cost and
speed of onset. For example, while Viagra can potentially
facilitate erections for a period of 10 hours, a 10 or 20mg
dose of Vardenafil will have a life of approximately 14
hours. Clinical trails of the new medication, which included
men with diabetes, have also been encouraging in that the
occurrence of side effects is reported to be significantly
less than Viagra. This is especially true for the incidence
of severe headaches, which in the past has been one of the
major negative drawbacks of Pfizer’s Viagra. There
is also some speculation that this new erectile medication
may not have the serious adverse reaction to nitroglycerine,
taken by many men with cardiac conditions. Medical clearance
however will continue to be important prior to starting
the medication.
Shortly
after Vardenafil hits the market, Lilly-ICOS should unveil
its new product sometime in 2003. Submitted for FDA approval
in June 2001, the Lilly-ICOS product, Tadalafil, is potentially
the erection medication that many men have waited for.
Originally
scheduled to be released in 2002, the FDA denied approval
in May 2002 and currently no dates have been announced.
Many people speculate however that once its safety has been
firmly documented Tadalafil will debut in 2003 with much
fanfare.
Tadalafil
may have the potential to revolutionize the whole field
of sexually related oral medications. Lilly-ICOS promises
it will be worth the wait.
The most astounding feature of Tadalafil is its length of
action. According to some reports, this new medication will
facilitate a man’s ability to achieve an erection for
as long as 36 to 48 hours! Thus in theory, one dose of Tadenafil
on a Friday night will provide the potential for the man
to achieve a rigid erection anytime he becomes sexually
aroused over the entire weekend. Concerns regarding the
need to plan for sex and the lack of spontaneity will be
virtually eliminated. Issues regarding cost will also be
reduced since a single pill will enhance erectile functioning
over an extended period of time.
Like
Bayer’s Vardenafil, The new Lilly-ICOS product has
apparently also addressed issues regarding safety and side
effects. In the clinical trials, the incidence of blue vision
has been totally eliminated and the occurrence of headaches
has also been significantly reduced. Although price has
not yet been established for either of these two new medications,
both pharmaceutical companies have stated that the prices
will be competitive with Pfizer’s Viagra.
In
conclusion, although the female pill has yet to be developed,
the second generation oral medications for erectile dysfunction
are about to make their debut. This will be especially encouraging
for the many men who found the results of Viagra to be disappointing
or ineffective. It will also provide men with several alternatives
that will reduce unwanted side effects, improve spontaneity
and potentially reduce the cost associated with the medication.
Clearly, these are revolutionary times in the field of sexual
medicine and the upcoming months are especially exciting.
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